Evaluation the efficacy of autologous platelet rich plasma (PRP) in prevention of hypertrophic scar at the site of sternotomy in adults with open heart surgery in Shahid Modarres Hospital in 2020-2021
Determining the efficacy of autologous platelet rich plasma in prevention of hypertrophic scar at the site of sternotomy in adults with open heart surgery
Design
Participants in this study are the adults over 18 years old who undergo open heart surgery in Shahid Modarres Hospital.Each patient on who the intervention is performed will be considered as his control.This study is single-blinded so that the evaluator of the hypertrophic scar's site doesn't know the location of the PRP injection.Based on similar articles, the sample size was calculated 50 people.For sampling, the people who have the inclusion criteria enroll in the study,after signing the informed consent.
Settings and conduct
The study is conducted in Shahid Modarres hospital.The people who undergo open heart surgery and have the inclusion criteria will enroll in the study.Their wound at the site of midsternotomy is divided into two parts.Then, 4 cc of PRP is injected randomly in one part and 4 cc of normal saline as placebo in the other part.The wound site will be evaluated at 2nd,12th and 24th weeks after surgery by a trained personnel who don't know in which part PRP has been injected.
Participants/Inclusion and exclusion criteria
Not having diabetes,autoimmune disease and thrombocytopenia;Not receiving glucocorticoids
Intervention groups
Before the surgery and injection of anesthetics and anticoagulants, a certain volume of blood is taken from the patient .PRP is prepared by an educated person with the help of a standard kit.The midsternal wound is divided into two parts. Randomly, PRP is injected into one half and normal saline solution in the other half as a placebo.Thus every patient is considered as control too. The scar formed at the wound site will be assessed at 2nd, 12th and 24th weeks after the surgery by an educated person not aware of the site of the PRP injection.
Main outcome variables
Hypertrophic scar score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201007048955N1
Registration date:2020-10-11, 1399/07/20
Registration timing:prospective
Last update:2020-10-11, 1399/07/20
Update count:0
Registration date
2020-10-11, 1399/07/20
Registrant information
Name
zahra ansari aval
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2208 3095
Email address
z.ansari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-11-22, 1400/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the efficacy of autologous platelet rich plasma (PRP) in prevention of hypertrophic scar at the site of sternotomy in adults with open heart surgery in Shahid Modarres Hospital in 2020-2021
Public title
Efficacy of autologous platelet rich plasma (PRP) in prevention of hypertrophic scar
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Not having diabetes
Not having autoimmune diseases
Not having thrombocytopenia(platelets below 150000)
Not receiving glucocorticoids
Exclusion criteria:
Patient not referring to the doctor for surveillance
Death of the patient during the surveillance period
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The patients' wound at the site of mid-sternotomy is divided into upper and lower parts, then 4 cc of PRP is randomly injected in one part and 4 cc of normal saline as placebo in the other part. Patients' wounds are then assessed at 2nd, 12th and 24th weeks after surgery by another person who does not know the injection site of PRP and placebo , and the hypertrophic scars in both areas is evaluated by using the Vancouver scar scale(VSS).
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shaheed Beheshti University of Medical Sciences and Health Services, Beside Taleghani Hospital,Tabnak St. , Evin, Shaheed Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-02-26, 1397/12/07
Ethics committee reference number
IR.SBMU.MSP.REC.1397.782
Health conditions studied
1
Description of health condition studied
Keloid and hypertrophic scar
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Hypertrophic scar score
Timepoint
2nd, 12th and 24th weeks after surgery
Method of measurement
Vancouver scar scale(VSS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Before the surgery and injection of anesthetics and anticoagulants, a certain volume of blood is taken from the patient .PRP is prepared by an educated person with the help of a standard kit. The midsternal wound is divided into two parts. Randomly, PRP is injected into one half and normal saline solution in the other half as a placebo. Thus every patient himself is considered as control too. The scar formed at the wound site will be assessed at 2nd, 12th and 24th weeks after the surgery by an educated person not aware of the site of the PRP injection.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modarress Educational Hospital
Full name of responsible person
Sadra Ashrafi
Street address
Shahid Modarress Educational Hospital, Saadat Abad St. Yadegare Imam Highway
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
modarres@sbmu.ac.ir
Web page address
http://modarres.sbmu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Clinical Research Development Center
Full name of responsible person
Naser Malekpour
Street address
Saadatabad intersection, Yadegar Imam Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
Nassermalekpour@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Clinical Research Development Center
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sadra Ashrafi
Position
Student of Medical Sciences
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
ُSchool of medicine, Shaheed Beheshti University of Medical Sciences and Health Services, Beside Taleghani Hospital, Tabnak St., Evin, Shaheed Chamran Avenue
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Fax
Email
sadra.ashrafi@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Ansari aval
Position
Deputy Director in education, Research shahid modarres medical center
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Shahid Modarres Hospital, Above Kaj Square, Saadat Abad
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2208 3095
Fax
Email
z.ansari@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sadra Ashrafi
Position
Student of Medical Sciences
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
School of medicine, Shaheed Beheshti University of Medical Sciences and Health Services, Beside Taleghani Hospital, Tabnak St., Evin, Shaheed Chamran Avenue
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Fax
Email
sadra.ashrafi@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
In order to protect the patients' personal information, the participants' data cannot be revealed.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available